Clinical Trials for Dilantin-125

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in
treating patients who have recurrent primary malignant glioma.

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Combining more than one drug may kill more tumor cells.
PURPOSE: Phase I trial to study the effectiveness of irinotecan plus temozolomide in
treating patients who have recurrent primary malignant glioma.

This study will determine whether the drugs tamoxifen and bortezomib can delay tumor growth
in patients with recurrent glioma (malignant brain tumor). Tamoxifen may work by interfering
with the internal signaling needed for the cancer to grow. Bortezomib may also interfere
with tumor growth processes. Laboratory studies show that low doses of bortezomib
significantly enhance glioma cell death when used with tamoxifen.
Patients 18 years of age and older with glioma whose tumor does not respond to standard
medical treatment and who are not taking enzyme-inducing anti-seizure medications such as
Dilantin, phenobarbitol, or Tegretol, may be eligible for this study. Candidates are
screened with a physical examination, blood tests, and magnetic resonance imaging (MRI) or
computed tomography (CT). MRI and CT scans produce images of the brain that can show if the
brain tumor is growing (see below).
Participants receive treatment in 6-week cycles for up to 1 year. (The treatment duration
may be extended in some patients who continue to tolerate the drug and show no signs of
tumor growth after 1 year.) During each cycle, patients take six tamoxifen tablets twice a
day every day and receive bortezomib by infusion into a vein on days 3, 6, 10, 13, 24, 27,
31 and 34. Treatment may continue as long as the tumor does not grow and the patient does
not develop unacceptable side effects. In addition to drug treatment, patients undergo the
following tests and procedures:
- Periodic routine blood tests.
- MRI or CT scan of the head before starting each new cycle. MRI uses a magnetic field
and radio waves to produce images of body tissues and organs. CT uses x-rays to provide
3-dimensional views of the part of the body being studied. For both procedures, the
patient lies on a table that slides into the cylindrical scanner.
- Blood test to measure levels of bortezomib. Blood is drawn before the bortezomib
infusion on days 3 and 24, and 4 hours after the infusion on day 24 of the first
treatment cycle only.
- Dynamic MRI with spectroscopy or positron emission tomography (PET). Patients may be
asked to undergo one of these tests, which help distinguish live tumor from dying
tumor. The experience of dynamic MRI with spectroscopy is the same as standard MRI and
is done at the same time as the standard procedure (see above). PET uses a radioactive
substance to show cellular activity in specific tissues of the body. The patient is
given an injection of a sugar solution in which a radioactive isotope has been attached
to the sugar molecule. A special camera detects the radiation emitted by the
radioisotope, and the resulting images show how much glucose is being used in various
parts of the body. Because rapidly growing cells, such as tumors, take up and use more
glucose than normal cells do, this test can be used to show active tumors.
- Drug diary. Patients maintain a calendar to record when they take their study drugs and
what side effects they develop.

It is unclear how enteral nutrition via a feeding tube should be given when a patient is
receiving enteral Dilantin. Some caregivers hold the feedings for one hour before and one
hour after the Dilantin dose to insure adequate absorption of the medication and some
caregivers think that the feedings do not need to be interrupted.
Hypothesis: Dilantin levels will remain therapeutic when enteral nutrition is given
continuously during the administration of enteral Dilantin.
The objective of this study is to determine Dilantin levels when enteral feedings are given
by the continuous method. Thirty patients will be studied. When Dilantin levels are in the
therapeutic range for 2 consecutive days on interrupted feedings (baseline), the patient
will be switched to continuous feedings uninterrupted for the medication, for 7 days.
Dilantin levels will be checked daily and if the levels become subtherapeutic an intravenous
(IV) bolus of Dilantin will be given and the enteral dose will be increased (doses
determined by primary caregiver). Serum albumin will be measured at baseline and at the
beginning and end of each week, in order to calculate free Dilantin.

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Phase 2

Men infected with the HIV virus (the virus that causes AIDS) often lose weight even though
they may try to eat more food to gain weight. The reasons for this weight loss are not
clear. Many men with HIV have low levels of testosterone in their blood. Testosterone is a
hormone that is naturally produced in the bodies of both men and women and has important
effects on building muscle and bone mass. The purpose of this study is to find out if
providing additional testosterone to HIV infected men who have low testosterone can help
them gain weight, increase their muscle mass, and feel better. The study will also help see
if testosterone improves the efficiency with which your body produces and uses energy
including fat. The dose of testosterone being used in this study will raise testosterone
levels in the blood to higher than normal levels (2-3 times normal level).

Phase I:
The purpose of this research study is to determine the safety of the combination treatment
of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas,
temozolomide (Temodar) and radiation therapy. This agent is investigational for the
treatment of glioblastomas. We will determine the highest dose of ZD6474 (Vandetanib) that
can be given safely when combined with temozolomide (Temodar) and radiation therapy.
Phase II:
The purpose of this research study is to determine the efficacy of the combination treatment
of ZD6474 (Vandetanib) with the standard therapy for glioblastomas and gliosarcomas,
temozolomide (Temodar) and radiation therapy. This agent is investigational for the
treatment of glioblastomas.
All subjects participating in this research study must NOT be taking a certain type of
anti-seizure medication called enzyme inducing anticonvulsant drugs. These drugs include
(but are not limited to) the following medications: Dilantin, Tegretol, Phenobarbital and
trileptal.

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